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Not yet recruitingNCT07595731Updated Jun 8, 2026

Kaleidoscope Compared to Tell-Show-Do for Reducing Children Pain and Anxiety During Pulp Therapy

An interventional study of behavior management using Kaleidoscope glasses (SOL, country of origin: China). and behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China). in Dental Anxiety in Children and Dental Pain, sponsored by Cairo University. Not yet recruiting. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
4 Years to 6 Years
Sex
All
01

Study summary

The goal of this clinical trial is to investigate if Kaleidoscope glasses help children feel less pain and worry during dental work. It will also explore if these glasses help children feel more comfortable with the dentist.

Kaleidoscope glasses are special glasses show bright, colorful shapes. The patterns change every time the child moves their head. This helps keep the child's mind off the dental work.

The main questions it aims to answer are:

Do the glasses lower a child's pain during a numbing shot and tooth treatment?

Do the glasses help a child feel less anxious during the visit?

Researchers will compare the glasses to a method called "Tell-Show-Do" to see which works best. "Tell-Show-Do" is when a dentist explains and shows tools before using them.

Participants will:

Get a nerve treatment (a "baby root canal") on a bottom baby tooth.

Wear the Kaleidoscope glasses, have the researcher use "Tell-Show-Do," or do both.

Have their pulse and pain levels checked before, during, and after the visit.

To keep the study fair, the child will be put into 1 of 3 groups by picking a sealed random envelope.

The groups are:

Group 1: The child wears Kaleidoscope glasses (the special glasses).

Group 2: The child wears Kaleidoscope glasses and the operator uses the "Tell-Show-Do" method during the visit with the child.

Group 3: The operator uses the "Tell-Show-Do" method during the visit with the child only.

This study helps make the dental visit easier and more comfortable for children. It aims to:

Lower pain during the tooth treatment. Help children feel less afraid of the dentist. Make children more willing to get the care they need. The research also helps dentists give better care by building trust with their young participants.

Risks:

There are no serious risks in this study. In rare cases, a child may not want to wear the special glasses. If this happens, the researcher will stop using the glasses but will still finish the tooth treatment.

02

Conditions studied

  • Dental Anxiety in Children
  • Dental Pain

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Keywords

  • managing dental pain in children
  • dental pain
  • dental pain in children
  • children anxiety
  • dental anxiety in children
  • behavior management
  • dental distraction
03

In context

Toothache

142 studies on the registry are indexed under Toothache; 28 are open to participants now.

This study's planned enrollment of 39 is below the median of 84 across 123 interventional studies indexed under Toothache.

Browse Toothache studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children aged between 4-6 years old.
  • Healthy with no systemic illness or allergies.
  • Indicated for pulp therapy in their lower primary molar.
  • Parents who agree to sign .

Exclusion criteria

Exclusion Criteria:

  • Children with systemic or mental disorders.
  • Children without parental consent.
  • Children complaining of acute dental pain.
  • Children receiving analgesics within the last 48 hours.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
39 participants (estimated)

Study arms

  • Active comparator
    Behavior management using the Tell-Show-Do technique during the treatment.

    Behavior management using the Tell-Show-Do technique during the treatment.

    Behavioral: behavior management using the Tell-Show-Do technique.

  • Experimental
    behavior management using Kaleidoscope glasses.

    behavior management while the child is wearing Kaleidoscope glasses (SOL, country of origin: China) during the treatment.

    Behavioral: behavior management using Kaleidoscope glasses (SOL, country of origin: China).

  • Experimental
    behavior management using the Tell-Show-Do technique and Kaleidoscope glasses

    behavior management using the Tell-Show-Do technique and while the child is wearing Kaleidoscope glasses (SOL, country of origin: China).

    Behavioral: behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China).

Interventions

  • Behavioralbehavior management using Kaleidoscope glasses (SOL, country of origin: China).

    behavior management using Kaleidoscope glasses (SOL, country of origin: China).

    Also known as: Kaleidoscope glasses (SOL, country of origin: China)., Kaleidoscope glasses, Kaleidoscope distarction

  • Behavioralbehavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China).

    behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China).

    Also known as: Tell-Show-Do, Tell show do, Kaleidoscope glasses

  • Behavioralbehavior management using the Tell-Show-Do technique.

    behavior management using the Tell-Show-Do technique.

    Also known as: Tell-Show-Do, TSD, tell show do

06

What researchers measure

Primary outcomes

  1. Assessment of pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale

    Assessment of pain using the FLACC scale: (Quantitative outcome) 0-10 score with 0 representing no pain and better outcome and data will be collected directly from participants.

    Time frame: Child's pain level will be assessed during Local anesthesia injection and pulpotomy by using the FLACC scale.

Secondary outcomes

  1. Assessment of dental anxiety

    Assessment of dental anxiety using finger Pulse oximeter (Quantitative outcome) scores(beats/min)

    Time frame: Child's anxiety level will be collected using a Pulse oximeter before behaviour management, pre-operatively after behaviour management, and within 5 minutes postoperatively.

  2. Assessment of dental anxiety using Facial Image Scale (FIS)

    Assessment of dental anxiety using Facial Image Scale (FIS): (Quantitative outcome) Image scores (1-5) with 1 (most positive child experience and best outcome) and 5 (most negative and worst outcome).

    Time frame: Child's anxiety level will be collected using a facial image scale before behaviour management, pre-operatively after behaviour management, and within 5 minutes postoperatively.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07595731
Lead sponsor
Cairo University
Responsible party
Nada Mosaad Abdel-Aziz (Master's Candidate, Cairo University) — Principal investigator
First posted
May 19, 2026
Start date
Jun 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
May 2027 (estimated)
Last update
Jun 8, 2026

Study contacts

Nada M. Abdelaziz, Bachelor degree
Contact
nada.mosaad@dentistry.cu.edu.eg
+201005171751

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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